FDA 510(k) clearances — page 790
clearances on record, most recent first.
Clearances — page 790
78,901–79,000 of 175,825- K011662 — MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
- K011663 — MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
- K002336 — MS104A, NEWMINI II (EMS-II), MODEL AP-101050T AND MEDTRIM (EMS-V), MODEL AP-102050T
- K002874 — WELL-TENS
- K010159 — DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
- K011140 — QUANTA PLEX ENA PROFILE 4
- K011334 — SYNTHES CURVED RECONSTRUCTION PLATE
- K011335 — SYNTHS ONE-THIRD TUBULAR DCL PLATE
- K011914 — HYDRO2, HS-75
- K012028 — ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5
- K012035 — BRAUN PRECISION SENSOR PRO, MODEL BP 2590
- K012060 — MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT
- K990667 — KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
- K011135 — GSI AUDERA
- K011332 — RF-IVD WIRELESS DOSIMETER-MODEL 1133
- K011998 — METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
- K012002 — VIKING OPTIMA GUIDING CATHETER
- K012031 — MODIFICATION TO THERMAL ANGEL
- K012095 — THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
- K012191 — TERATECH MODEL 2000 HANDHELD ULTRASOUND SYSTEM WITH DOPPLER AND HARMONIC IMAGING MODES
- K001508 — LASERSKIN DRESSING
- K003949 — TACKER, MODEL R65-933
- K010006 — DRAINAGE CATHETER OR FOLEY CATHETER
- K010270 — TREMOROMETER
- K010337 — LIPOPRINT SYSTEM, LDL SUBFRACTIONS
- K011325 — MEDIFIX URETEROSCOPE
- K011689 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
- K011692 — HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
- K011718 — BAUSCH & LOMB SOFLENS ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT
- K011780 — K-ASSAY C1-INA
- K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
- K011968 — STREERABLE PTCA GUIDEWIRE
- K012024 — EBI XFIX DFS SYSTEM
- K012159 — RAPID DRUG SCREEN
- K010400 — VACUUM ASSISTED CORE BIOPSY DEVICE
- K011207 — LASER PERIPHERALS REUSABLE HOLMIUM FIBER
- K011281 — INTUITIVE SURGICAL ULTRASONIC SHEARS
- K011999 — MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM
- K012005 — MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM
- K012034 — MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
- K012171 — MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
- K010317 — AV 800 VENTILATOR
- K010318 — PRIMA OXYGEN MONITOR
- K010415 — ISODAN
- K011438 — BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
- K011453 — TOOTH SHADE RESIN MATERIAL
- K011520 — RESTORE-X
- K011830 — TRI-FIX SPINAL FIXATION SYSTEM
- K012178 — FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW
- K012207 — ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530
- K003802 — HYSTEROSCOPES
- K003805 — GYNECOLOGICAL LAPAROSCOPES
- K003831 — ARTHROSCOPES
- K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
- K010911 — MACROPORE OS SPINAL SYSTEM
- K011118 — NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
- K011235 — SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
- K011253 — FLAVORED MALE LATEX CONDOM
- K011310 — NIEN MADE NON-INVASIVE BLOOD PRESSURE MONITOR, MODELS HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1
- K011319 — STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
- K011345 — CARDIONAVIGATOR INFORMATION MANAGEMENT SYSTEM
- K011352 — ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
- K011539 — ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
- K011599 — ALKALINE PHOSPHATASE LIQUID REAGENT
- K011874 — FADASIS MEDICAL FM-1 NO BLENDER
- K012016 — INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
- K012019 — COLOR BUFFED (CB) DDH FEMORAL STEM
- K012027 — MODIFICATION TO XIA SPINE SYSTEM
- K012094 — MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
- K012107 — LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
- K012131 — LIVESURE BENZODIAZEPINES SCREEN TESTS
- K012133 — LIVESURE BARBITURATES SCREEN TEST
- K012194 — BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
- K983332 — NORTHEAST PROTON THERAPY CENTER
- K004003 — PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075, 2RCS10, 2RCS15, 2RCS20, 2RCS225, 2RCS30
- K004025 — SPLITTABLE SHEATH INTRODUCER KIT
- K011279 — ENTEC EVAC PLASMA WAND
- K011296 — INFINION ENHANCEMENT PACKAGE
- K011360 — MTP LAPAROMAT DISPOSABLE TUBING SET
- K011452 — CAVEX STABISIL
- K011501 — ENDOPOUCH RETRIEVER
- K011549 — OHMEDA MEDICAL SPOT PT LITE PHOTOTHERAPY SYSTEM
- K011904 — NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
- K011969 — SYNTHES CERVIFIX SYSTEM
- K012057 — CASCADE BATH, MODEL 6900
- K012061 — SUPERIOR BATH, MODEL 6300
- K003364 — VIVO 200 DPS VIVOSCAN
- K003709 — SURGICAL DYNAMICS MESH CAGE SYSTEM
- K010681 — SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
- K011206 — PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES
- K011216 — PVC FREE INTRAVASCULAR ADMINISTRATION SET
- K011312 — BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
- K011455 — BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
- K011552 — UROLOGICAL CATHETER
- K011756 — ADMIRA FLOW
- K011881 — DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
- K011938 — OIL FOR EMBRYO CULTURE
- K011957 — IVENT 201 PORTABLE VENTILATOR
- K012000 — 1.5MM BONE FIXATION KIT
- K012001 — SMARTSCREW
Data sourced from openFDA. This site is unofficial and independent of the FDA.